The goal of this clinical trial is to evaluate the efficacy and influencing factors of the combination of the anterior limb of internal capsule and nucleus accumbens (ALIC-NAc) deep brain stimulation (DBS) in patients with treatment-refractory obsessive-compulsive disorder (OCD). The main questions it aims to answer is:
Does the timing of DBS activation (at 1, 2, or 3 months post-surgery) affect the reduction rate in Y-BOCS scores? Researchers will compare three groups-DBS activated at 1, 2, and 3 months post-surgery-to determine whether earlier or later stimulation leads to greater symptom improvement.
Participants will:
* Undergo surgical implantation of an intracranial neurostimulation system targeting ALIC-NAc * Be randomly assigned to one of three DBS activation timing groups * Receive regular clinical assessments over a 6-month follow-up period after activation
aged 18-65 years old;
a diagnosis of OCD based on The Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5);
the Y-BOCS total score ≥ 25;
met the criteria of treatment refractory. Treatment refractory is defined as failed a) Inadequate response or intolerance to at least three adequate trials of selective serotonin reuptake inhibitors (SSRIs), combined with at least two second-generation antipsychotics as augmentation agents.
Presence of other psychiatric disorders such as organic mental disorders, paranoid personality disorder, or mental retardation.
Individuals deemed by the investigator to be at significant risk of suicidal behavior based on clinical assessment.
Presence of severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, endocrine, neurological, or other systemic diseases.
History of organic brain disorders, traumatic brain injury, intractable epilepsy, or other neurological conditions.
Parallel
deep brain stimulation
DeviceDeep Brain Stimulation (DBS) involves the use of stereotactic techniques to implant microelectrodes into specific target nuclei within the brain through minimally invasive surgery. These electrodes are connected via leads to a subcutaneously implanted pulse generator, typically placed beneath the clavicle. By delivering low-intensity electrical pulses, DBS suppresses abnormal intracranial neural activity, thereby alleviating symptoms. Long-term stimulation can also induce neuroplastic changes in neural networks and neurotransmitter systems, contributing to the restoration of neurological function.
Obsessive-compulsive symptoms improvement
The severity of OCD symptoms is assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Obsessive-compulsive symptoms improvement is reflected by Y-BOCS reduction rate.
the change scores of CGI score
The Clinical Global Impressions (CGI) is an invaluable tool for monitoring the treatment outcomes of patients. The CGI actually comprises three companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7, (b) change from the initiation of treatment on a similar seven-point scale, and (c) an overall evaluation of the therapeutic effect and side effects.
the change scores of HAMD score
The Hamilton Depression Rating Scale (HAM-D) is used to quantify the severity of symptoms of depression and is one of the most widely used and accepted instruments for assessing depression. It contains 24 items rated on 5-point scale, with the sum of all items making up the total score, yielding total scores from zero to 96. The higher score means more severity of depression symptoms.
the change scores of HAMA score
The Hamilton Anxiety Rating Scale (HAM-A) was one of the first rating scales developed to measure the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety and somatic anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
the change of SF-36 score
The Short Form-36 Health Survey (SF-36) comprises eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health. It also includes one item assessing perceived health change. These domains can be summarized into two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Click on the lead sponsor to view all of their trials.
Shanghai Mental Health Center
Lead sponsor
Huashan Hospital
Collaborator
The First Affiliated Hospital of Shanxi Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Tianjin Anding Hospital
Collaborator
Tianjin Huanhu Hospital
Collaborator
The First Hospital of Hebei Medical University
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
The Second Affiliated Hospital of Xinxiang Medical College
Collaborator
the Third Hospital of Mianyang
Collaborator
